BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 4092009 · Received August 21, 2014

    Report

    Report Number
    9681442-2014-00120
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 11, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, THIS EVENT IS BEING REPORTED UNDER REGULATION 21 CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE UNITED STATES UNDER #P070014. AS THE LOT NUMBER OF THE SUBJECT DEVICE HAS NOT BEEN PROVIDED, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT WAS FOUND TO BE CONSTRICTED IN THE MIDDLE SECTION AFTER SUCCESSFUL IMPLANTATION IN THE SFA. DURING THE PERFORMED POST-DILATION, THE VASCULAR STENT COULD NOT BE COMPLETELY EXPANDED AND ANOTHER STENT WAS PLACED INSIDE THE NARROWED STENT. A FURTHER STENT WAS PLACED ADJACENT TO THE FIRST STENT TO FULLY COVER THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504544 LIFESTENT VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention